Obesity, Type 2 Diabetes
Conditions
Keywords
Gut Microbiota, inflammatory marker, Glucose and lipid metabolism
Brief summary
The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.
Interventions
DRUGSaxagliptin (Bristol-Myers Squibb Company)
6-month treatment of Saxagliptin 5mg Qd
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females or males, and aged 20 to 65 years. * Newly diagnosed type 2 diabetes * HbA1C ≥7% and HbA1C \<9%
Exclusion criteria
* Hepatic insufficiency (ALT or AST\> 1.5\*ULN) * Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation) * Coronary artery disease * Thyroid disease * Infectious disease * Systemic inflammatory disease * Cancer * Subjects who were taking agents known to influence gut microbiota * Pregnant or lactating woman * Other conditions at investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gut microbiota | Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The improvement of intestinal microflora imbalance | Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks) | — |
| The change of inflammatory markers | The change of inflammatory markers (baseline, 12 weeks) | The effect on plasma levels of inflammatory markers, such as IL-1B, IL-6 and TNF-α(baseline, 12 weeks) |
Outcome results
None listed